Visit 3: Operation

  1. StudyEvent: PREBOT Pilot
    1. Visit 1: Enrollment and Randomization
    2. Visit 2: Endoscopic intervention
    3. Visit 3: Operation
    4. Visit 4: POD 3
    5. Visit 5: Day of discharge
    6. Visit 6: POD 30
    7. Visit 7: 3 months post OP/ premature discontinuation
    8. Signature
  2. StudyEvent: Complications
    1. Complications
  3. StudyEvent: Readmission To Hospital (repeatable instrument)
    1. Readmission To Hospital (repeatable instrument)
  4. StudyEvent: Adverse Events (repeatable instrument)
    1. Adverse Events (repeatable instrument)
  5. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  6. StudyEvent: Protocol Violation (repeatable instrument)
    1. Protocol Violation (repeatable instrument)
  7. StudyEvent: Patient report: EORTC QLQ-C30
  8. StudyEvent: Patient report: EORTC QLQ-PAN26
Laboratory Parameters (prior to surgery)
Beschrijving

Laboratory Parameters (prior to surgery)

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0543467
Date of blood test
Beschrijving

Date of blood test

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0849535
Measurement of Pancreatic amylase
Beschrijving

Measurement of Pancreatic amylase

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274428
If yes: Pancreatic amylase
Beschrijving

Pancreatic amylase

Datatype

float

Maateenheden
  • U/I
Alias
UMLS CUI [1,1]
C0301812
U/I
Measurement of lipase
Beschrijving

Measurement of lipase

Datatype

boolean

Alias
UMLS CUI [1,1]
C0373670
If yes: Lipase
Beschrijving

Lipase

Datatype

integer

Maateenheden
  • U/l
Alias
UMLS CUI [1,1]
C0023764
U/l
Bilirubin
Beschrijving

Bilirubin

Datatype

float

Maateenheden
  • mg/dl
Alias
UMLS CUI [1,1]
C0201913
mg/dl
Hemoglobin
Beschrijving

Hemoglobin

Datatype

float

Maateenheden
  • g/dl
Alias
UMLS CUI [1,1]
C0019046
g/dl
Erythrocytes
Beschrijving

Erythrocytes

Datatype

float

Maateenheden
  • /pl
Alias
UMLS CUI [1,1]
C0014792
/pl
Leucocytes
Beschrijving

Leucocytes

Datatype

float

Maateenheden
  • /nl
Alias
UMLS CUI [1,1]
C0023516
/nl
Thrombocytes
Beschrijving

Thrombocytes

Datatype

float

Maateenheden
  • /nl
Alias
UMLS CUI [1,1]
C0005821
/nl
INR
Beschrijving

INR

Datatype

float

Alias
UMLS CUI [1,1]
C0525032
Creatinine clearance / GFR (estimated by Cockroft-Gault)
Beschrijving

GFR

Datatype

float

Maateenheden
  • ml/min
Alias
UMLS CUI [1,1]
C2711451
UMLS CUI [1,2]
C0373595
ml/min
CRP
Beschrijving

CRP

Datatype

float

Maateenheden
  • mg/l
Alias
UMLS CUI [1,1]
C0201657
mg/l
Complications (prior to surgery)
Beschrijving

Complications (prior to surgery)

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0543467
Postinterventional pancreatitis
Beschrijving

Postinterventional pancreatitis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030305
UMLS CUI [1,2]
C3272301
If yes, please fill out eForm 'Adverse Events'
Beschrijving

If yes, please fill out eForm 'Adverse Events'

Alias
UMLS CUI [1,1]
C3273494
UMLS CUI [1,2]
C0877248
Distal Pancreatectomy
Beschrijving

Distal Pancreatectomy

Alias
UMLS CUI [1,1]
C0176940
Distal Pancreatectomy performed
Beschrijving

Distal Pancreatectomy performed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0176940
UMLS CUI [1,2]
C0450010
If no, please specify reason
Beschrijving

specify reason

Datatype

integer

Alias
UMLS CUI [1,1]
C1521902
If other, please specify reason
Beschrijving

Specify

Datatype

text

Alias
UMLS CUI [1,1]
C1521902
If no distal pancreatectomy performed, please do data entry in eCRF as follows: 1. remaining documentation of Visit 3: Operation 2. skip Visit 4-6 and fill out 'premature trial termination' for reason DP not performed in Visit 7 3. documentation of AEs necessary for planned FU time of 3 months 4. eCRF signature
Beschrijving

If no distal pancreatectomy performed, please do data entry in eCRF as follows: 1. remaining documentation of Visit 3: Operation 2. skip Visit 4-6 and fill out 'premature trial termination' for reason DP not performed in Visit 7 3. documentation of AEs necessary for planned FU time of 3 months 4. eCRF signature

Alias
UMLS CUI [1,1]
C3273494
If no distal pancreatectomy performed, please do data entry in eCRF as follows: 1. remaining documentation of Visit 3: Operation 2. skip Visit 4-6 and fill out 'premature trial termination' for reason DP not performed in Visit 7 3. eCRF signature
Beschrijving

If no distal pancreatectomy performed, please do data entry in eCRF as follows: 1. remaining documentation of Visit 3: Operation 2. skip Visit 4-6 and fill out 'premature trial termination' for reason DP not performed in Visit 7 3. eCRF signature

Alias
UMLS CUI [1,1]
C3273494
Surgery details
Beschrijving

Surgery details

Alias
UMLS CUI [1,1]
C5204320
Date of distal pancreatectomy
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0176940
Beginning of skin incision
Beschrijving

Skin incision

Datatype

time

Alias
UMLS CUI [1,1]
C2116297
End of skin closure
Beschrijving

Skin closure

Datatype

time

Alias
UMLS CUI [1,1]
C1883250
UMLS CUI [1,2]
C0040223
Technique of surgery
Beschrijving

Technique

Datatype

integer

Alias
UMLS CUI [1,1]
C0449851
If minimally invasive, please specify
Beschrijving

Specify

Datatype

integer

Alias
UMLS CUI [1,1]
C1521902
Type of pancreatic transection
Beschrijving

Type of pancreatic transection

Datatype

integer

Alias
UMLS CUI [1,1]
C0434050
UMLS CUI [1,2]
C0332307
If other, please specify
Beschrijving

Specify

Datatype

text

Alias
UMLS CUI [1,1]
C1521902
Additional covering of the pancreatic remnant of any kind (e.g. ligamentum teres hepatis patch, mesh implantation or use of fibrin glue)
Beschrijving

covering of pancreatic remnant

Datatype

boolean

Alias
UMLS CUI [1,1]
C4554476
UMLS CUI [1,2]
0030274
UMLS CUI [1,3]
C0439844
Location of the resection margin (in relation to the superior mesenterial/portal vein axis)
Beschrijving

Location of the resection margin

Datatype

integer

Alias
UMLS CUI [1,1]
C0229985
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0933844
UMLS CUI [1,4]
C0032718
UMLS CUI [1,5]
C0226742
Texture of pancreatic tissue
Beschrijving

Texture of pancreatic tissue

Datatype

integer

Alias
UMLS CUI [1,1]
C1280424
UMLS CUI [1,2]
C0679033
Determination of pancreatic duct size
Beschrijving

Determination of pancreatic duct size

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030288
UMLS CUI [1,2]
C0456389
If yes: Pancreatic duct size
Beschrijving

Pancreatic duct size

Datatype

integer

Maateenheden
  • mm
Alias
UMLS CUI [1,1]
C1521902
mm
Additional resections performed
Beschrijving

Additional resections performed

Datatype

boolean

Alias
UMLS CUI [1,1]
C1706712
UMLS CUI [1,2]
C0728940
Intraoperative blood loss
Beschrijving

Intraoperative blood loss

Datatype

float

Maateenheden
  • ml
Alias
UMLS CUI [1,1]
C5208110
ml
Red blood cell transfusion during surgery
Beschrijving

Perioperative RBC transfusion

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C1518988
If yes: Volume of red blood cell transfusion
Beschrijving

Volume RBC transfusion

Datatype

float

Maateenheden
  • ml
Alias
UMLS CUI [1,1]
C0523098
ml
If yes, please specify
Beschrijving

If yes, please specify

Alias
UMLS CUI [1,1]
C1521902
splenectomy
Beschrijving

splenectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037995
adrenalectomy
Beschrijving

adrenalectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001632
colectomy
Beschrijving

colectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009274
vascular resection
Beschrijving

vascular resection

Datatype

boolean

Alias
UMLS CUI [1,1]
C0728940
UMLS CUI [1,2]
C1801960
cholecystectomy
Beschrijving

cholecystectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008320
other
Beschrijving

other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205394
If other additional resection, please specify
Beschrijving

specify

Datatype

text

Alias
UMLS CUI [1,1]
C1521902
If vascular resection, please specify
Beschrijving

If vascular resection, please specify

Alias
UMLS CUI [1,1]
C1521902
portal vein / superior mesenteric vein
Beschrijving

portal vein / superior mesenteric vein

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032718
UMLS CUI [1,2]
C0226742
inferior vena cava
Beschrijving

inferior vena cava

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042458
celiac trunc
Beschrijving

celiac trunc

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007569
hepatic artery
Beschrijving

hepatic artery

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019145
superior mesenteric artery
Beschrijving

superior mesenteric artery

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162861
Octreotide
Beschrijving

Octreotide

Alias
UMLS CUI [1,1]
C0028833
Perioperative application of octreotide (e.g. Sandostatin)
Beschrijving

Perioperative Octreotide

Datatype

boolean

Alias
UMLS CUI [1,1]
C1518988
UMLS CUI [1,2]
C3469597
Perioperativ Sepsis
Beschrijving

Perioperativ Sepsis

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C1518988
Occurence of perioperativ Sepsis
Beschrijving

Occurence

Datatype

boolean

Alias
UMLS CUI [1,1]
C2745955
If yes, please fill out eForm 'Adverse Events'
Beschrijving

If yes, please fill out eForm 'Adverse Events'

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3273494
Concomitant Medication
Beschrijving

Concomitant Medication

Alias
UMLS CUI [1,1]
C2347852
Any changes in Concomitant Medication since last visit
Beschrijving

Changes in Concomitant Medication since last visit

Datatype

boolean

Alias
UMLS CUI [1,1]
C3872643
UMLS CUI [1,2]
C0580105
If yes, please fill out eForm 'Concomitant Medication'
Beschrijving

If yes, please fill out eForm 'Concomitant Medication'

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C1521902
Adverse Events
Beschrijving

Adverse Events

Alias
UMLS CUI [1,1]
C3872643
Any new Adverse Events occurred since last visit
Beschrijving

Adverse Events since last visit

Datatype

boolean

Alias
UMLS CUI [1,1]
C3872643
UMLS CUI [1,2]
C0205314
If yes, please fill out eForm 'Adverse Events'
Beschrijving

If yes, please fill out eForm 'Adverse Events'

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3273494
Protocol violations
Beschrijving

Protocol violations

Alias
UMLS CUI [1,1]
C1709750
Any protocol violations occurred since last visit
Beschrijving

Protocol violations occurred since last visit

Datatype

boolean

Alias
UMLS CUI [1,1]
C1291910
UMLS CUI [1,2]
C3872643
If yes, please fill out eForm 'Protocol Violations'
Beschrijving

If yes, please fill out eForm 'Protocol Violations'

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C3273494

Similar models

Visit 3: Operation

  1. StudyEvent: PREBOT Pilot
    1. Visit 1: Enrollment and Randomization
    2. Visit 2: Endoscopic intervention
    3. Visit 3: Operation
    4. Visit 4: POD 3
    5. Visit 5: Day of discharge
    6. Visit 6: POD 30
    7. Visit 7: 3 months post OP/ premature discontinuation
    8. Signature
  2. StudyEvent: Complications
    1. Complications
  3. StudyEvent: Readmission To Hospital (repeatable instrument)
    1. Readmission To Hospital (repeatable instrument)
  4. StudyEvent: Adverse Events (repeatable instrument)
    1. Adverse Events (repeatable instrument)
  5. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  6. StudyEvent: Protocol Violation (repeatable instrument)
    1. Protocol Violation (repeatable instrument)
  7. StudyEvent: Patient report: EORTC QLQ-C30
  8. StudyEvent: Patient report: EORTC QLQ-PAN26
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Laboratory Parameters (prior to surgery)
C1254595 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Date of blood test
Item
Date of blood test
date
C0011008 (UMLS CUI [1,1])
C0849535 (UMLS CUI [1,2])
Measurement of Pancreatic amylase
Item
Measurement of Pancreatic amylase
boolean
C3274428 (UMLS CUI [1,1])
Pancreatic amylase
Item
If yes: Pancreatic amylase
float
C0301812 (UMLS CUI [1,1])
Measurement of lipase
Item
Measurement of lipase
boolean
C0373670 (UMLS CUI [1,1])
Lipase
Item
If yes: Lipase
integer
C0023764 (UMLS CUI [1,1])
Bilirubin
Item
Bilirubin
float
C0201913 (UMLS CUI [1,1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1,1])
Erythrocytes
Item
Erythrocytes
float
C0014792 (UMLS CUI [1,1])
Leucocytes
Item
Leucocytes
float
C0023516 (UMLS CUI [1,1])
Thrombocytes
Item
Thrombocytes
float
C0005821 (UMLS CUI [1,1])
INR
Item
INR
float
C0525032 (UMLS CUI [1,1])
GFR
Item
Creatinine clearance / GFR (estimated by Cockroft-Gault)
float
C2711451 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
CRP
Item
CRP
float
C0201657 (UMLS CUI [1,1])
Item Group
Complications (prior to surgery)
C0009566 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Postinterventional pancreatitis
Item
Postinterventional pancreatitis
boolean
C0030305 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
Item Group
If yes, please fill out eForm 'Adverse Events'
C3273494 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
Distal Pancreatectomy
C0176940 (UMLS CUI [1,1])
Distal Pancreatectomy performed
Item
Distal Pancreatectomy performed
boolean
C0176940 (UMLS CUI [1,1])
C0450010 (UMLS CUI [1,2])
Item
If no, please specify reason
integer
C1521902 (UMLS CUI [1,1])
Code List
If no, please specify reason
CL Item
inoperability (1)
C0205187 (UMLS CUI [1,1])
CL Item
partial pancreatoduodenectomy performed (2)
C0728938 (UMLS CUI [1,1])
C0085162 (UMLS CUI [1,2])
CL Item
total pancreatectomy performed (3)
C0040511 (UMLS CUI [1,1])
CL Item
other (4)
C0205394 (UMLS CUI [1,1])
Specify
Item
If other, please specify reason
text
C1521902 (UMLS CUI [1,1])
Item Group
If no distal pancreatectomy performed, please do data entry in eCRF as follows: 1. remaining documentation of Visit 3: Operation 2. skip Visit 4-6 and fill out 'premature trial termination' for reason DP not performed in Visit 7 3. documentation of AEs necessary for planned FU time of 3 months 4. eCRF signature
C3273494 (UMLS CUI [1,1])
Item Group
If no distal pancreatectomy performed, please do data entry in eCRF as follows: 1. remaining documentation of Visit 3: Operation 2. skip Visit 4-6 and fill out 'premature trial termination' for reason DP not performed in Visit 7 3. eCRF signature
C3273494 (UMLS CUI [1,1])
Item Group
Surgery details
C5204320 (UMLS CUI [1,1])
Date
Item
Date of distal pancreatectomy
date
C0011008 (UMLS CUI [1,1])
C0176940 (UMLS CUI [1,2])
Skin incision
Item
Beginning of skin incision
time
C2116297 (UMLS CUI [1,1])
Skin closure
Item
End of skin closure
time
C1883250 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Technique of surgery
integer
C0449851 (UMLS CUI [1,1])
Code List
Technique of surgery
CL Item
minimally invasive (1)
C0282624 (UMLS CUI [1,1])
CL Item
open surgery (2)
C0348025 (UMLS CUI [1,1])
Item
If minimally invasive, please specify
integer
C1521902 (UMLS CUI [1,1])
Code List
If minimally invasive, please specify
CL Item
laparoscopic (1)
C0751429 (UMLS CUI [1,1])
CL Item
robotic (2)
C3850136 (UMLS CUI [1,1])
Item
Type of pancreatic transection
integer
C0434050 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Type of pancreatic transection
CL Item
scalpel with suture closure of the cut margin (1)
C0392220 (UMLS CUI [1,1])
C0009068 (UMLS CUI [1,2])
CL Item
linear stapler (2)
C1139962 (UMLS CUI [1,1])
CL Item
other (3)
C0205394 (UMLS CUI [1,1])
Specify
Item
If other, please specify
text
C1521902 (UMLS CUI [1,1])
covering of pancreatic remnant
Item
Additional covering of the pancreatic remnant of any kind (e.g. ligamentum teres hepatis patch, mesh implantation or use of fibrin glue)
boolean
C4554476 (UMLS CUI [1,1])
0030274 (UMLS CUI [1,2])
C0439844 (UMLS CUI [1,3])
Item
Location of the resection margin (in relation to the superior mesenterial/portal vein axis)
integer
C0229985 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0933844 (UMLS CUI [1,3])
C0032718 (UMLS CUI [1,4])
C0226742 (UMLS CUI [1,5])
Code List
Location of the resection margin (in relation to the superior mesenterial/portal vein axis)
CL Item
left (1)
C0205091 (UMLS CUI [1,1])
CL Item
above (2)
C0456745 (UMLS CUI [1,1])
CL Item
right (3)
C0205090 (UMLS CUI [1,1])
Item
Texture of pancreatic tissue
integer
C1280424 (UMLS CUI [1,1])
C0679033 (UMLS CUI [1,2])
Code List
Texture of pancreatic tissue
CL Item
soft (1)
C0205358 (UMLS CUI [1,1])
CL Item
intermediate (2)
C0205103 (UMLS CUI [1,1])
CL Item
hard (3)
C0018599 (UMLS CUI [1,1])
Determination of pancreatic duct size
Item
Determination of pancreatic duct size
boolean
C0030288 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Pancreatic duct size
Item
If yes: Pancreatic duct size
integer
C1521902 (UMLS CUI [1,1])
Additional resections performed
Item
Additional resections performed
boolean
C1706712 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
Intraoperative blood loss
Item
Intraoperative blood loss
float
C5208110 (UMLS CUI [1,1])
Perioperative RBC transfusion
Item
Red blood cell transfusion during surgery
boolean
C0086252 (UMLS CUI [1,1])
C1518988 (UMLS CUI [1,2])
Volume RBC transfusion
Item
If yes: Volume of red blood cell transfusion
float
C0523098 (UMLS CUI [1,1])
Item Group
If yes, please specify
C1521902 (UMLS CUI [1,1])
splenectomy
Item
splenectomy
boolean
C0037995 (UMLS CUI [1,1])
adrenalectomy
Item
adrenalectomy
boolean
C0001632 (UMLS CUI [1,1])
colectomy
Item
colectomy
boolean
C0009274 (UMLS CUI [1,1])
vascular resection
Item
vascular resection
boolean
C0728940 (UMLS CUI [1,1])
C1801960 (UMLS CUI [1,2])
cholecystectomy
Item
cholecystectomy
boolean
C0008320 (UMLS CUI [1,1])
other
Item
other
boolean
C0205394 (UMLS CUI [1,1])
specify
Item
If other additional resection, please specify
text
C1521902 (UMLS CUI [1,1])
Item Group
If vascular resection, please specify
C1521902 (UMLS CUI [1,1])
portal vein / superior mesenteric vein
Item
portal vein / superior mesenteric vein
boolean
C0032718 (UMLS CUI [1,1])
C0226742 (UMLS CUI [1,2])
inferior vena cava
Item
inferior vena cava
boolean
C0042458 (UMLS CUI [1,1])
celiac trunc
Item
celiac trunc
boolean
C0007569 (UMLS CUI [1,1])
hepatic artery
Item
hepatic artery
boolean
C0019145 (UMLS CUI [1,1])
superior mesenteric artery
Item
superior mesenteric artery
boolean
C0162861 (UMLS CUI [1,1])
Item Group
Octreotide
C0028833 (UMLS CUI [1,1])
Perioperative Octreotide
Item
Perioperative application of octreotide (e.g. Sandostatin)
boolean
C1518988 (UMLS CUI [1,1])
C3469597 (UMLS CUI [1,2])
Item Group
Perioperativ Sepsis
C0243026 (UMLS CUI [1,1])
C1518988 (UMLS CUI [1,2])
Occurence
Item
Occurence of perioperativ Sepsis
boolean
C2745955 (UMLS CUI [1,1])
Item Group
If yes, please fill out eForm 'Adverse Events'
C0877248 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
Item Group
Concomitant Medication
C2347852 (UMLS CUI [1,1])
Changes in Concomitant Medication since last visit
Item
Any changes in Concomitant Medication since last visit
boolean
C3872643 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
Item Group
If yes, please fill out eForm 'Concomitant Medication'
C2347852 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Adverse Events
C3872643 (UMLS CUI [1,1])
Adverse Events since last visit
Item
Any new Adverse Events occurred since last visit
boolean
C3872643 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
Item Group
If yes, please fill out eForm 'Adverse Events'
C0877248 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
Item Group
Protocol violations
C1709750 (UMLS CUI [1,1])
Protocol violations occurred since last visit
Item
Any protocol violations occurred since last visit
boolean
C1291910 (UMLS CUI [1,1])
C3872643 (UMLS CUI [1,2])
Item Group
If yes, please fill out eForm 'Protocol Violations'
C1709750 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])